It has become increasingly important for the prevention and treatment of disease as well as the maintenance of good health for people to supplement the normal intake of food with nutritional and/or dietary supplements. Typically, these substances are required to be taken several times a day in order to fulfill the daily dosage requirements. Many nutritional and/or dietary substances are not well stored by the body requiring frequent dosing. However, the more doses required, the less compliance there is by the patient. People simply will not take the number of pills required to complete the daily dosage requirements. The reasons for failing to take proper dosages include inconvenience, difficulty in swallowing pills, forgetfulness and the like. In addition, the generally poor taste of many nutritional and/or dietary substances adds to the difficulty in completing dosage regimens.
There have been efforts to develop dosage systems which seek to make active ingredients more pleasant and effective for the consumer. In order to provide a pleasant tasting composition and one which provides the desired benefits, it is necessary for the nutritional and/or dietary dosage system meet the following requirements.
The system must provide for both nutritional and dietary active ingredients. The system must also be able to deliver both water soluble and water insoluble active ingredients. A sustained-release system must also be provided so that active ingredients which are required to be administered over a long period may be slowly delivered rather than all at once. The formulation must be readily dissolvable in a liquid, particularly water to provide a pleasant tasting drink. Finally, administration of the composition must be sufficient to provide an optimum delivery of the active ingredients so that the composition is effective until the next dosage which may be as much as approximately 24 hours later.
Efforts have been made to meet the above-stated criteria of a nutritional and/or dietary supplement formulation. For example, Nakomoto, U.S. Pat. No. 3,773,920, discloses sustained-release granules which provide for a water soluble medicament contained within an ethylcellulose polymer to provide uniform release velocity and complete release of the medicament.
Huber, U.S. Pat. No. 4,122,157, discloses a preparation for the administration of nitrofurantoin. The composition is in the form of a sustained-release tablet which is taken orally. The tablet contains a rapid release component and a slow release component for the same drug. It is further stated that the composition contains an effervescent agent.
Glassman, U.S. Pat. No. 4,503,031, discloses a two section tablet for the administration of drugs including a sustained-release component. Sodium bicarbonate is employed as an effervescent agent.
Ashmead, U.S. Pat. No. 4,725,427, discloses a vitamin-mineral combination for both water soluble and water insoluble active ingredients. An effervescent agent is provided so that the composition is dissolvable in water.
Briggs et al., U.S. Pat. No. 4,752,479, disclose an iron containing dietary supplement for oral administration in which an inner core contains iron and a waxy film former of ethylcellulose is provided around the core.
Barry et al., U.S. Pat. No. 5,055,306, disclose an effervescent tablet which includes a sustained-release formulation comprising a core containing the active ingredient and a coating which is water swellable.
Wehling et al., U.S. Pat. No. 5,178,878, disclose an effervescent composition for oral administration which employs microparticles of an active ingredient including vitamins and minerals.
Radebaugh et al., U.S. Pat. No. 5,200,193, disclose tablets which contain a sustained-release formulation using ethylcellulose as a matrix. The tablets contain drugs such as ibuprofen as the active ingredient.
Hagemann et al., U.S. Pat. No. 5,211,957, disclose an effervescent tablet for diclofenac providing both immediate and delayed release of the active ingredient.
Wehling et al., U.S. Pat. No. 5,223,264, disclose an oral pediatric vitamin supplement in tablet form containing an effervescent agent.
Zema et al., U.S. Pat. No. 5,306,506, disclose a water composition containing a drug as an active ingredient which is microencapsulated to delay release and mask the taste of the active ingredient. Ethylcellulose is used as a membrane for the microencapsulation.
Eichel et al., U.S. Pat. No. 5,376,384, disclose a sustained-release formulation for water soluble drugs employing a diffusion barrier.
While all of these references disclose dosage formulations effectively administering an active ingredient through tablet or liquid form, none of the references provide an acceptable means of administering a nutritional and/or dietary supplement in as little as a single daily dosage form which can accommodate both water soluble and water insoluble nutritional and/or dietary active ingredients and provide a system by which the same can be delivered both immediately and through sustained-release.